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| Sponsor: | University of Connecticut Health Center |
|---|---|
| Collaborator: |
National Center for Research Resources (NCRR) |
| Information provided by: | University of Connecticut Health Center |
| ClinicalTrials.gov Identifier: | NCT00755716 |
Purpose
Specific aims:
| Condition | Intervention | Phase |
|---|---|---|
|
Tobacco Dependence |
Drug: Placebo Drug: topiramate Drug: topiramate plus nicotine patch |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Topiramate Alone and in Combination With the Nicotine Patch for Smoking Cessation: A Pilot Study |
| Enrollment: | 84 |
| Study Start Date: | April 2006 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: group 1
Person receive an inactive placebo
|
Drug: Placebo
patients receive
Other Name: topimax
|
|
Active Comparator: 2
topiramate capsules
|
Drug: topiramate
25 mg per day for one week, 50 mg per day for one week, 100 mg per day for one week, 200 mg per day for 5 weeks, then one week taper
Other Name: topimax
|
|
Active Comparator: 3
topiramate plus nicotine patch
|
Drug: topiramate plus nicotine patch
subjects receive 10 weeks of topirmate with a dosage starting at 25 mg per day. At week two (quit date) subjects increase to 50 mg/day and gradually increase to 200 mg/day for a total time of 10 weeks. On the quit date (after 2 weeks of medication use), subjects also use 21mg patch for 8 weeks.
Other Name: topimax, nicoderm
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion criteria:
Contacts and Locations| United States, Connecticut | |
| University of Connecticut Halth Center | |
| Farmington, Connecticut, United States, 06030 | |
| Principal Investigator: | Cheryl A Oncken, MD | University of Conneciticut Health Center |
More Information
| Responsible Party: | Cheryl Oncken, MD, University of Connecticut School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00755716 History of Changes |
| Other Study ID Numbers: | 06-114-1, 006192 |
| Study First Received: | September 18, 2008 |
| Last Updated: | August 3, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
nicotine patch smoking topiramate |
|
Smoking Tobacco Use Disorder Habits Substance-Related Disorders Mental Disorders Nicotine Nicotine polacrilex Topiramate Ganglionic Stimulants Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses Anticonvulsants Neuroprotective Agents Protective Agents Anti-Obesity Agents |